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The Quantum Vertebral Body Replacement System is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture).

This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with allograft or autograft.

The Quantum Vertebral Body Replacement System is composed of a flanged VBR body with screw holes and fixation screws. The body is a generally box-shaped device with various holes located throughout its geometry and teeth on its external surfaces. Screws pass through screw holes and affix to bone to help prevent implant migration. The devices are available in a multitude of sizes and are made from titanium and polyetheretherketone (PEEK).

The provided text describes a medical device, the Quantum Vertebral Body Replacement System, and its intended use, but it does not include the detailed information requested regarding acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert ground truth establishment, or multi-reader comparative effectiveness studies.

The document is a 510(k) summary for a medical device submitted to the FDA for clearance. It focuses on demonstrating substantial equivalence to a predicate device and includes information about the device's description, intended use, and a statement about performance data.

Here's a breakdown of what can be extracted and what is missing:

What is present in the document:

• Device Identification: Quantum Vertebral Body Replacement System
• Intended Use: To replace a collapsed, damaged, or unstable vertebral body in the thoracic and/or thoracolumbar spine (T1-L5) due to tumor or trauma (fracture), to be used with supplemental spinal fixation systems.
• Performance Data Statement: "Mechanical testing indicates that the Quantum Vertebral Body Replacement System is capable of performing in accordance with its intended use."

What is missing from the document and therefore cannot be provided in the requested format:

1. A table of acceptance criteria and the reported device performance: The document only states "Mechanical testing indicates that the Quantum Vertebral Body Replacement System is capable of performing in accordance with its intended use." It does not specify any quantitative acceptance criteria (e.g., minimum strength, fatigue life, displacement limits) nor does it provide reported numerical performance results against such criteria.
2. Sample size used for the test set and the data provenance: Not mentioned. The "performance data" refers to mechanical testing, not a clinical study with a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is a mechanical device, not an AI/imaging device requiring expert interpretation for ground truth.
4. Adjudication method for the test set: Not applicable for mechanical testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is a mechanical implant, not an AI system assisting human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical implant, not an algorithm.
7. The type of ground truth used: For mechanical testing, "ground truth" would be the engineering specifications and validated test methods. The document does not detail these.
8. The sample size for the training set: Not applicable. This is a mechanical device, not an AI system requiring a "training set."
9. How the ground truth for the training set was established: Not applicable.

Conclusion:

The provided 510(k) summary focuses on the regulatory clearance process for a mechanical medical device through substantial equivalence to a predicate, rather than providing detailed performance study data against specific acceptance criteria for a diagnostic or AI-based device. Therefore, the majority of the requested information, which pertains to performance studies for software-based or diagnostic devices, is not available in the given text.

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